Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment

Purpose

This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.

Condition

  • Plasma Cell Myeloma

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration - Participants must have measurable disease within 28 days prior to registration as defined by any of the following: - Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >= 0.5 gram/deciliter [g/dL] or urine M-protein level >= 200 milligram[mg]/24 hours[hrs]); OR - IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level >= 0.2 g/dL or urine M-protein level >= 200 mg/24 hrs); OR - Light chain multiple myeloma (serum immunoglobulin free light chain >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio) - All disease must be assessed and documented on the baseline/pre-registration tumor assessment form - Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http://www.myelomafrailtyscorecalculator.net/) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration - For Participants Meeting "Frail" Status: - Participants with any degree of kidney dysfunction are allowed; however, participants on dialysis are not eligible - For Participants Meeting "Frail" Status: - Hemoglobin >= 7 g/dL (must be performed within 28 days prior to registration) - Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) - For Participants Meeting "Frail" Status: - Platelets >= 50 x 10^9/L (must be performed within 28 days prior to registration) - Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) - For Participants Meeting "Frail" Status: - Absolute neutrophil count (ANC) >= 0.75 x10^9/L (must be performed within 28 days prior to registration) - Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) - For Participants Meeting "Intermediate Fit" Status, one or more of the following criteria must be present: - Kidney dysfunction showing calculated creatinine clearance (CrCl) <30 ml/min. - Actual lab serum creatinine value with a minimum of 0.7 mg/dL. - Participants must have bone marrow function assessed and meet the below criteria ranges: - Hemoglobin between 7-8 g/dL, OR - Platelets between 50-75 x10^9/L, OR - ANC between 0.75-1 x10^9/L - Note: growth factor and transfusion utilization are allowed as long as cytopenias are considered secondary to bone marrow involvement from MM) - Revised International Staging System (R-ISS) stage III disease - Note: All labs must be performed within 28 days prior to registration - Participants must have a complete medical history and physical exam within 28 days prior to registration - Participants must have whole body imaging within 60 days prior to registration. The recommended method of imaging is a positron emission tomography/computed tomography (PET/CT); a low-dose whole body CT scan or whole-body magnetic resonance imaging (MRI) or skeletal survey should be done only if a PET/CT scan cannot be done or is non-feasible. This must be documented in the comments section of the Onstudy form. - Total bilirubin =< 2 times institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN (within 28 days prior to registration) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 × institutional ULN (within 28 days prior to registration) - Participants must have adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must not be assessed as class 3 or 4 - Participants with known diabetes must show evidence of controlled disease within 14 days prior to registration. Uncontrolled diabetes is defined as: A glycosylated hemoglobin (Hg)A1C > 7 - Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test result obtained, within 6 months prior to registration - All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration - Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, participant must have an undetectable HCV viral load within 28 days prior to registration - Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status score of 0-2 (Note: Participants with ECOG/Zubrod performance score [PS] 3, especially where the deterioration of PS is considered secondary to the MM diagnosis, will be allowed) - Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system - Participants who are able to complete the patient-reported outcomes measures in English or Spanish must agree to participate in the PRO portion of the study - Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Exclusion Criteria

  • Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following: - An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or - Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or - Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol. - Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration - Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) > 90 mmHg. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 14 days prior to registration must be SBP =< 140 and DBP =< 90. A participant with a single blood pressure elevation who upon rechecking has a normal blood pressure will remain eligible at the discretion of the registering investigator. - Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen. - Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm I (VRd-Lite)
INDUCTION CYCLES 1-9: Patients receive bortezomib SC on days 1, 8, 15, and 22 of each cycle, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Drug: Bortezomib
    Given SC
    Other names:
    • [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid
    • LDP 341
    • MLN341
    • PS-341
    • PS341
    • Velcade
  • Drug: Dexamethasone
    Given PO
    Other names:
    • Aacidexam
    • Adexone
    • Aknichthol Dexa
    • Alba-Dex
    • Alin
    • Alin Depot
    • Alin Oftalmico
    • Amplidermis
    • Anemul mono
    • Auricularum
    • Auxiloson
    • Baycadron
    • Baycuten
    • Baycuten N
    • Cortidexason
    • Cortisumman
    • Decacort
    • Decadrol
    • Decadron
    • Decadron DP
    • Decalix
    • Decameth
    • Decasone R.p.
    • Dectancyl
    • Dekacort
    • Deltafluorene
    • Deronil
    • Desamethasone
    • Desameton
    • Dexa-Mamallet
    • Dexa-Rhinosan
    • Dexa-Scheroson
    • Dexa-sine
    • Dexacortal
    • Dexacortin
    • Dexafarma
    • Dexafluorene
    • Dexalocal
    • Dexamecortin
    • Dexameth
    • Dexamethasone Intensol
    • Dexamethasonum
    • Dexamonozon
    • Dexapos
    • Dexinoral
    • Dexone
    • Dinormon
    • Dxevo
    • Fluorodelta
    • Fortecortin
    • Gammacorten
    • Hemady
    • Hexadecadrol
    • Hexadrol
    • Lokalison-F
    • Loverine
    • Methylfluorprednisolone
    • Millicorten
    • Mymethasone
    • Orgadrone
    • Spersadex
    • TaperDex
    • Visumetazone
    • ZoDex
  • Drug: Lenalidomide
    Given PO
    Other names:
    • CC-5013
    • CC5013
    • CDC 501
    • Revlimid
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Experimental
Arm II (DRd-R)
INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Drug: Daratumumab and Hyaluronidase-fihj
    Given SC
    Other names:
    • DARA Co-formulated with rHuPH20
    • DARA/rHuPH20
    • Daratumumab + rHuPH20
    • Daratumumab with rHuPH20
    • Daratumumab-rHuPH20
    • Daratumumab/Hyaluronidase-fihj
    • Daratumumab/rHuPH20 Co-formulation
    • Darzalex Faspro
    • Darzalex/rHuPH20
    • HuMax-CD38-rHuPH20
    • Recombinant Human Hyaluronidase Mixed with Daratumumab
  • Drug: Dexamethasone
    Given PO
    Other names:
    • Aacidexam
    • Adexone
    • Aknichthol Dexa
    • Alba-Dex
    • Alin
    • Alin Depot
    • Alin Oftalmico
    • Amplidermis
    • Anemul mono
    • Auricularum
    • Auxiloson
    • Baycadron
    • Baycuten
    • Baycuten N
    • Cortidexason
    • Cortisumman
    • Decacort
    • Decadrol
    • Decadron
    • Decadron DP
    • Decalix
    • Decameth
    • Decasone R.p.
    • Dectancyl
    • Dekacort
    • Deltafluorene
    • Deronil
    • Desamethasone
    • Desameton
    • Dexa-Mamallet
    • Dexa-Rhinosan
    • Dexa-Scheroson
    • Dexa-sine
    • Dexacortal
    • Dexacortin
    • Dexafarma
    • Dexafluorene
    • Dexalocal
    • Dexamecortin
    • Dexameth
    • Dexamethasone Intensol
    • Dexamethasonum
    • Dexamonozon
    • Dexapos
    • Dexinoral
    • Dexone
    • Dinormon
    • Dxevo
    • Fluorodelta
    • Fortecortin
    • Gammacorten
    • Hemady
    • Hexadecadrol
    • Hexadrol
    • Lokalison-F
    • Loverine
    • Methylfluorprednisolone
    • Millicorten
    • Mymethasone
    • Orgadrone
    • Spersadex
    • TaperDex
    • Visumetazone
    • ZoDex
  • Drug: Lenalidomide
    Given PO
    Other names:
    • CC-5013
    • CC5013
    • CDC 501
    • Revlimid
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Experimental
Arm III (DRd-DR):
INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Drug: Daratumumab and Hyaluronidase-fihj
    Given SC
    Other names:
    • DARA Co-formulated with rHuPH20
    • DARA/rHuPH20
    • Daratumumab + rHuPH20
    • Daratumumab with rHuPH20
    • Daratumumab-rHuPH20
    • Daratumumab/Hyaluronidase-fihj
    • Daratumumab/rHuPH20 Co-formulation
    • Darzalex Faspro
    • Darzalex/rHuPH20
    • HuMax-CD38-rHuPH20
    • Recombinant Human Hyaluronidase Mixed with Daratumumab
  • Drug: Dexamethasone
    Given PO
    Other names:
    • Aacidexam
    • Adexone
    • Aknichthol Dexa
    • Alba-Dex
    • Alin
    • Alin Depot
    • Alin Oftalmico
    • Amplidermis
    • Anemul mono
    • Auricularum
    • Auxiloson
    • Baycadron
    • Baycuten
    • Baycuten N
    • Cortidexason
    • Cortisumman
    • Decacort
    • Decadrol
    • Decadron
    • Decadron DP
    • Decalix
    • Decameth
    • Decasone R.p.
    • Dectancyl
    • Dekacort
    • Deltafluorene
    • Deronil
    • Desamethasone
    • Desameton
    • Dexa-Mamallet
    • Dexa-Rhinosan
    • Dexa-Scheroson
    • Dexa-sine
    • Dexacortal
    • Dexacortin
    • Dexafarma
    • Dexafluorene
    • Dexalocal
    • Dexamecortin
    • Dexameth
    • Dexamethasone Intensol
    • Dexamethasonum
    • Dexamonozon
    • Dexapos
    • Dexinoral
    • Dexone
    • Dinormon
    • Dxevo
    • Fluorodelta
    • Fortecortin
    • Gammacorten
    • Hemady
    • Hexadecadrol
    • Hexadrol
    • Lokalison-F
    • Loverine
    • Methylfluorprednisolone
    • Millicorten
    • Mymethasone
    • Orgadrone
    • Spersadex
    • TaperDex
    • Visumetazone
    • ZoDex
  • Drug: Lenalidomide
    Given PO
    Other names:
    • CC-5013
    • CC5013
    • CDC 501
    • Revlimid
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Anchorage Radiation Therapy Center
Anchorage, Alaska 99504
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Cancer Center at Saint Joseph's
Phoenix, Arizona 85004
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
Contact:
Site Public Contact
800-378-9373

CARTI Cancer Center
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-906-4199
Research@CARTI.com

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California 93420
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Site Public Contact
720-874-1881
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Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505
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Site Public Contact
818-847-4793
Najee.Boucher@providence.org

Marshall Cancer Center
Cameron Park, California 95682
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530-672-7050
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Mercy Cancer Center - Carmichael
Carmichael, California 95608
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720-874-1881
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Mercy San Juan Medical Center
Carmichael, California 95608
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916-556-3301
OncologyResearch@DignityHealth.org

Mercy Cancer Center - Elk Grove
Elk Grove, California 95758
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720-874-1881
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Fremont - Rideout Cancer Center
Marysville, California 95901
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Site Public Contact
530-749-4400

Mercy UC Davis Cancer Center
Merced, California 95340
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720-874-1881
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Providence Queen of The Valley
Napa, California 94558
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707-521-3830

Mercy Cancer Center - Rocklin
Rocklin, California 95765
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720-874-1881
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Mercy Cancer Center - Sacramento
Sacramento, California 95816
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720-874-1881
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University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
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916-734-3089

Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401
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720-874-1881
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Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444
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720-874-1881
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Providence Medical Foundation - Santa Rosa
Santa Rosa, California 95403
Contact:
Site Public Contact
707-521-3830

Providence Santa Rosa Memorial Hospital
Santa Rosa, California 95405
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707-521-3830

Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California 96161
Contact:
Site Public Contact
530-582-6450

Woodland Memorial Hospital
Woodland, California 95695
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720-874-1881
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Rocky Mountain Regional VA Medical Center
Aurora, Colorado 80045
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Site Public Contact
888-336-8262

Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
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720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
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720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Francis Cancer Center
Colorado Springs, Colorado 80923
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720-874-1881
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Mercy Medical Center
Durango, Colorado 81301
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720-874-1881
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Southwest Oncology PC
Durango, Colorado 81301
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720-874-1881
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Saint Anthony Hospital
Lakewood, Colorado 80228
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720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Longmont United Hospital
Longmont, Colorado 80501
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720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Mary Corwin Medical Center
Pueblo, Colorado 81004
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720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut 06418
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut 06824
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Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut 06033
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Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut 06830
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203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut 06437
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203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut 06105
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203-785-5702
canceranswers@yale.edu

Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut 06510
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203-785-5702
canceranswers@yale.edu

Yale University
New Haven, Connecticut 06520
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203-785-5702
canceranswers@yale.edu

Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut 06473
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203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut 06902
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canceranswers@yale.edu

Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut 06790
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203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611
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203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut 06708
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203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385
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Site Public Contact
203-785-5702
canceranswers@yale.edu

Holy Cross Hospital
Fort Lauderdale, Florida 33308
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Site Public Contact
eileen.georgi@holy-cross.com

Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
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Site Public Contact
855-776-0015

Jupiter Medical Center
Jupiter, Florida 33458
Contact:
Site Public Contact
561-745-5768

Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
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Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
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Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686
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Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
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Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Anthony's Health
Alton, Illinois 62002
Contact:
Site Public Contact
618-463-5623

Rush - Copley Medical Center
Aurora, Illinois 60504
Contact:
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

Saint Joseph Medical Center
Bloomington, Illinois 61701
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois 60527
Contact:
Site Public Contact
708-216-9000

Illinois CancerCare-Canton
Canton, Illinois 61520
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Memorial Hospital of Carbondale
Carbondale, Illinois 62902
Contact:
Site Public Contact
618-457-5200
clinical.research@sih.net

SIH Cancer Institute
Carterville, Illinois 62918
Contact:
Site Public Contact
618-985-3333
clinical.research@sih.net

Illinois CancerCare-Carthage
Carthage, Illinois 62321
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Centralia Oncology Clinic
Centralia, Illinois 62801
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Saint Mary's Hospital
Centralia, Illinois 62801
Contact:
Site Public Contact
protocols@swog.org

Carle at The Riverfront
Danville, Illinois 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Dixon
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800

Carle Physician Group-Effingham
Effingham, Illinois 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Eureka
Eureka, Illinois 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-344-2831

Edward Hines Jr VA Hospital
Hines, Illinois 60141
Contact:
Site Public Contact
708-202-8387

Loyola Medicine Homer Glen
Homer Glen, Illinois 60491
Contact:
Site Public Contact
708-216-9000

Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Macomb
Macomb, Illinois 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357

Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois 60160
Contact:
Site Public Contact
708-450-4554

Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864
Contact:
Site Public Contact
618-242-4600

Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Peoria, Illinois 61636
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru, Illinois 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Valley Radiation Oncology
Peru, Illinois 61354
Contact:
Site Public Contact
815-664-4141

Illinois CancerCare-Princeton
Princeton, Illinois 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

The Carle Foundation Hospital
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Illinois CancerCare - Washington
Washington, Illinois 61571
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Rush-Copley Healthcare Center
Yorkville, Illinois 60560
Contact:
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

IU Health North Hospital
Carmel, Indiana 46032
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

Northwest Cancer Center - Main Campus
Crown Point, Indiana 46307
Contact:
Site Public Contact
219-310-2550

Northwest Oncology LLC
Dyer, Indiana 46311
Contact:
Site Public Contact
219-924-8178

Northwest Cancer Center - Hobart
Hobart, Indiana 46342
Contact:
Site Public Contact
219-947-1795

Saint Mary Medical Center
Hobart, Indiana 46342
Contact:
Site Public Contact
219-836-6875
CancerResearch@COMHS.org

Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

Saint Catherine Hospital
Indianapolis, Indiana 46312
Contact:
Site Public Contact
protocols@swog.org

The Community Hospital
Munster, Indiana 46321
Contact:
Site Public Contact
219-836-3349

Women's Diagnostic Center - Munster
Munster, Indiana 46321
Contact:
Site Public Contact
219-934-8869
mnicholson@comhs.org

Reid Health
Richmond, Indiana 47374
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Northwest Cancer Center - Valparaiso
Valparaiso, Indiana 46383
Contact:
Site Public Contact
219-836-6875
CancerResearch@COMHS.org

Mission Cancer and Blood - Ankeny
Ankeny, Iowa 50023
Contact:
Site Public Contact
515-282-2921

University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa 52722
Contact:
Site Public Contact
563-355-7733
kedaprile@rccqc.com

Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa 52402
Contact:
Site Public Contact
319-297-2900

Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
Contact:
Site Public Contact
515-241-3305

Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

Greater Regional Medical Center
Creston, Iowa 50801
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Laurel
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-241-3305

University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
Contact:
Site Public Contact
800-237-1225

Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

Central Care Cancer Center - Garden City
Garden City, Kansas 67846
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Flaget Memorial Hospital
Bardstown, Kentucky 40004
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Commonwealth Cancer Center-Corbin
Corbin, Kentucky 40701
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Hospital
Lexington, Kentucky 40504
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Hospital East
Lexington, Kentucky 40509
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph London
London, Kentucky 40741
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Mount Sterling
Mount Sterling, Kentucky 40353
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Greater Baltimore Medical Center
Baltimore, Maryland 21204
Contact:
Site Public Contact
443-849-3706

Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Bronson Battle Creek
Battle Creek, Michigan 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Caro Cancer Center
Caro, Michigan 48723
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Ascension Saint John Hospital
Detroit, Michigan 48236
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan 48054
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Genesee Hematology Oncology PC
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Genesys Hurley Cancer Institute
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Hurley Medical Center
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-267-1925
crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan 48236
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Borgess Medical Center
Kalamazoo, Michigan 49048
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
Contact:
Site Public Contact
517-364-3712
harsha.trivedi@umhsparrow.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan 48453
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
Contact:
Site Public Contact
616-391-1230

Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Contact:
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

21st Century Oncology-Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
248-858-6215
Emily.Crofts@trinity-health.org

Hope Cancer Center
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Corewell Health Reed City Hospital
Reed City, Michigan 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan 48312
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Ascension Saint Joseph Hospital
Tawas City, Michigan 48764
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Munson Medical Center
Traverse City, Michigan 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Advanced Breast Care Center PLLC
Warren, Michigan 48088
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan 48093
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Macomb Hematology Oncology PC
Warren, Michigan 48093
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Michigan Breast Specialists-Warren
Warren, Michigan 48093
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

University of Michigan Health - West
Wyoming, Michigan 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Huron Gastroenterology PC
Ypsilanti, Michigan 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Riverwood Healthcare Center
Aitkin, Minnesota 56431
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health - Baxter Clinic
Baxter, Minnesota 56425
Contact:
Site Public Contact
218-828-2880

Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Cambridge Medical Center
Cambridge, Minnesota 55008
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Mercy Hospital
Coon Rapids, Minnesota 55433
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota 56501
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Cancer Center
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Saint Mary's Medical Center
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Miller-Dwan Hospital
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Fairview Southdale Hospital
Edina, Minnesota 55435
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health - Ely Clinic
Ely, Minnesota 55731
Contact:
Site Public Contact
218-365-7900

Essentia Health - Fosston
Fosston, Minnesota 56542
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Contact:
Site Public Contact
218-786-3308

Essentia Health - International Falls Clinic
International Falls, Minnesota 56649
Contact:
Site Public Contact
218-283-9431

Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Hennepin County Medical Center
Minneapolis, Minnesota 55415
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Health Partners Inc
Minneapolis, Minnesota 55454
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Monticello Cancer Center
Monticello, Minnesota 55362
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health - Moose Lake Clinic
Moose Lake, Minnesota 55767
Contact:
Site Public Contact
218-485-4481

New Ulm Medical Center
New Ulm, Minnesota 56073
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health - Park Rapids
Park Rapids, Minnesota 56470
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Fairview Northland Medical Center
Princeton, Minnesota 55371
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Site Public Contact
855-776-0015

Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Regions Hospital
Saint Paul, Minnesota 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

United Hospital
Saint Paul, Minnesota 55102
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health Sandstone
Sandstone, Minnesota 55072
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Lakeview Hospital
Stillwater, Minnesota 55082
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota 56701
Contact:
Site Public Contact
605-312-3320

Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Ridgeview Medical Center
Waconia, Minnesota 55387
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Rice Memorial Hospital
Willmar, Minnesota 56201
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Sanford Cancer Center Worthington
Worthington, Minnesota 56187
Contact:
Site Public Contact
605-312-3320

Fairview Lakes Medical Center
Wyoming, Minnesota 55092
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
Contact:
Site Public Contact
314-251-7058

Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Cox Cancer Center Branson
Branson, Missouri 65616
Contact:
Site Public Contact
417-269-4520

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Southeast Cancer Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-651-5550

Parkland Health Center - Farmington
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569

Capital Region Southwest Campus
Jefferson City, Missouri 65109
Contact:
Site Public Contact
573-632-4851
amy.franken@health.missouri.edu

Freeman Health System
Joplin, Missouri 64804
Contact:
Site Public Contact
417-347-4030
LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Joplin, Missouri 64804
Contact:
Site Public Contact
417-556-3074
esmeralda.carrillo@mercy.net

Research Medical Center
Kansas City, Missouri 64132
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Lake Regional Hospital
Osage Beach, Missouri 65065
Contact:
Site Public Contact
573-302-2768
clinicaltrials@lakeregional.com

Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-6379

Heartland Regional Medical Center
Saint Joseph, Missouri 64506
Contact:
Site Public Contact
816-271-7937
linda.schumacher@mymlc.com

Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri 63109
Contact:
Site Public Contact
314-353-1870

Mercy Hospital South
Saint Louis, Missouri 63128
Contact:
Site Public Contact
314-525-6042
Danielle.Werle@mercy.net

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520

CoxHealth South Hospital
Springfield, Missouri 65807
Contact:
Site Public Contact
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Armes Family Cancer Center
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Blanchard Valley Hospital
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Orion Cancer Care
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Wayne Hospital
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Greater Dayton Cancer Center
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Mercy Hospital Oklahoma City
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Saint Charles Health System
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Geisinger Medical Center
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Avera Cancer Institute-Aberdeen
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MD Anderson in The Woodlands
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Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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West Virginia University Charleston Division
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Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
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ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
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Duluth Clinic Ashland
Ashland, Wisconsin 54806
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Northwest Wisconsin Cancer Center
Ashland, Wisconsin 54806
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Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin 54729
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Essentia Health-Hayward Clinic
Hayward, Wisconsin 54843
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La Crosse, Wisconsin 54601
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Medford, Wisconsin 54451
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Minocqua, Wisconsin 54548
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Neillsville, Wisconsin 54456
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Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
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Ascension Saint Mary's Hospital
Rhinelander, Wisconsin 54501
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Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
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Essentia Health-Spooner Clinic
Spooner, Wisconsin 54801
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Ascension Saint Michael's Hospital
Stevens Point, Wisconsin 54481
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Stevens Point, Wisconsin 54482
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Superior, Wisconsin 54880
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Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
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Marshfield Clinic-Wausau Center
Wausau, Wisconsin 54401
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Marshfield Medical Center - Weston
Weston, Wisconsin 54476
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Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
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Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin 54494
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More Details

NCT ID
NCT05561387
Status
Recruiting
Sponsor
SWOG Cancer Research Network

Study Contact

Sharon Palmer
210-614-8808
spalmer@swog.org

Detailed Description

PRIMARY OBJECTIVES: I. To compare progression-free survival (PFS) in frail or selected intermediate fit newly diagnosed multiple myeloma (NDMM) participants treated with bortezomib with lenalidomide and dexamethasone at reduced dosing (VRd-Lite) induction followed by lenalidomide maintenance (Arm 1) versus daratumumab and hyaluronidase-fihj with lenalidomide and dexamethasone (DRd) induction followed by lenalidomide maintenance (Arm 2). II. To compare overall survival (OS) in frail or selected intermediate fit NDMM participants treated with VRd-Lite induction followed by lenalidomide maintenance (Arm 1) versus DRd induction followed by lenalidomide and daratumumab and hyaluronidase-fihj maintenance (Arm 3). SECONDARY OBJECTIVES: I. To compare PFS in Arm 1 versus Arm 3 II. To compare OS in Arm 1 versus Arm 2. III. To compare PFS in Arm 2 versus 3. IV. To compare the overall response rate (ORR) of Arm 1 against the ORR of Arm 2 and Arm 3. V. To compare the safety of Arm 1 with the safety of Arm 2 and Arm 3. VI. To explore veinous thrombo-embolism (VTE) incidence in participants receiving lenalidomide during induction across the three study arms. VII. To describe median time to response (complete response [CR] or better per International Myeloma Working Group [IMWG] criteria, very good partial response [VGPR] or better per IMWG criteria, partial response [PR] or better per IMWG criteria) on the three study arms. PRIMARY QUALITY OF LIFE (QOL) OBJECTIVE: I. To compare patient-reported global health status between treatment arms (Arm 1 versus the combination of Arms 2 and 3) at 9 months after randomization (end of induction therapy) using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30). SECONDARY QOL OBJECTIVE: II. To compare longitudinal changes in global health status between treatment arms (Arm 1 versus the combination of Arms 2 and 3) from baseline to 9 months after randomization (end of induction therapy). PATIENT REPORTED OUTCOMES-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (PRO-CTCAE) OBJECTIVE: I. To compare selected patient-reported outcome symptoms using PRO-CTCAE items among the 3 study arms. ADDITIONAL OBJECTIVES: I. To compare the rate of minimal residual disease (MRD) by clonoSEQ after 9 cycles of induction in Arm 1 versus Arm 2 and Arm 3, respectively. II. To compare the rate of MRD conversion after 1 year of maintenance in participants who were MRD positive after induction in Arm 1 versus Arm 2 and Arm 3, respectively. III. To compare the rate of sustained MRD negativity at time points of post-induction, post-1 year maintenance in Arm 1 versus Arm 2 and Arm 3, respectively. BANKING OBJECTIVES: I. To bank specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I (VRd-Lite): INDUCTION CYCLES 1-9: Patients receive bortezomib subcutaneously (SC) on days 1, 8, 15, and 22 of each cycle, lenalidomide orally (PO) on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II (DRd-R): INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM III (DRd-DR): INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years.